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2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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Background
● Ms. Physics and Eng., PhD Industrial engineering / Design research
○ Incl. Cognitive psychology
● Engineering management / Medical devices
● Regulatory Affairs and Quality Assurance
○ FDA, TGA, EU
○ HW / Systems
○ SW / AI
● AI - Singularity - Tech Ethics
○ Intelligence - Conscience/Consciousness
●Audio/Music
● Mental Health
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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Motivation
● ATHT.ORG
○ NFP
○ 2 Sides
● Rejuvenate my research and education profile
○ Value Engineering - Co-evolution / Design
○ Opportunity for silo breaking
● DIY (Mental) Health
○ Resolving cognitive dissonance
■ Values
■ Contributing back
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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Contents
● Regulations for tech (incl. AI) in mental health
○ Who and What?
○ Link with Ethics
● So what?
○ SWOT
● Transparency and future research
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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Regulations? What (is the “thing” regulated …. or not!)
and by whom ?
● The (medical) act
○ Intervention/therapy, diagnostic/test, education/prevention
■ Enhancement/modification
● “Wellness”
■ Self-practice and illegal practice
■ Research
● The tech itself
○ HW, SW, Data
■ Codes, Models, Datasets
■ Case of “instructions” for building the tech
○ For apps:
■ The HW running the app
■ The distribution channel (Apple/Android store…)
● The combination of tech and use:
○ “Intended use” (manufacturer’s label) vs. actual use
○ User = patient or professional?
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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Regulating research
● Ethics committees / IRBs…
○ Nuremberg to Helsinki
● Differences “investigator initiated”
versus “sponsor initiated” trials.
○ Scientific publications vs closed-source
“commercial in confidence” regulatory
reports.
● Data. HIPPA. GDPR
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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Regulating the tech (and its use)
● Regulatory Bodies
● Intended use and indications
for use
● Pre market
● Post Market
Medical device’ means any instrument, apparatus,
implement, machine, appliance, implant, reagent for in
vitro use, software, material or other similar or related
article, intended by the manufacturer to be used, alone or
in combination, for human beings, for one or more of the
specific medical purpose(s) of:
•diagnosis, prevention, monitoring, treatment or alleviation of
disease,
•diagnosis, monitoring, treatment, alleviation of or
compensation for an injury,
•investigation, replacement, modification, or support of the
anatomy or of a physiological process,
•supporting or sustaining life,
•control of conception,
•disinfection of medical devices
•providing information by means of in vitro examination of
specimens derived from the human body;
Does not achieve its primary intended action by
pharmacological, immunological or metabolic means, in or
on the human body, but which may be assisted in its
intended function by such means. (Those are “drugs”)
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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Regulating the tech (and its use)
● Classification
○ Aka thresholds
● Quality Management System
● Safety and Effectiveness / Conformity
○ Principles
○ Equivalence
● Risk Management
○ Risk - Benefit
● Design controls
○ Inputs … Validation
● Tech Standards
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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SWOT
● Discrete class and thresholds:
○ Historical legacy from a bureaucratic system
○ Responsible for chaotic behaviour and energy wasting navigation
○ Not intuitive (condom = critical care ventilator)
○ Barrier to entry - missing out on benefits
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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SWOT
Silo Spectrum - continuum Silo
From experimental trials to standard of care
● Ethics & values differences between
○ RCT (science)
○ Case Studies (conscience)
● LMICs trials
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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SWOT
● Classification
○ Aka thresholds
● Quality Management System
● Safety and Effectiveness / Conformity
○ Principles as VALUES
○ Equivalence
● Risk Management
○ Risk - Benefit
○ With transparency
● Design controls
○ Inputs … Validation
● Tech Standards
○ Yes...but
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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SWOT
Inspirations (to ‘cope’ with AI)
Science Arts
Explicit Implicit
Explainability Intuition
Societal introspection
Political correctness
Collective consciousness
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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SWOT
Innovation 1.0 Invention
Innovation 2.0 Collective / within the boundaries of incorporated entities (or gvt)
Innovation 3.0 Collective / without boundaries
Innovation 4.0 + AI
Hard science world
Concepts world
Mental health
Physical health
Neurology
Genomics
Atoms
Bits
Memetics?
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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Conclusion
● Regulations need to evolve. To be ethical, they must:
○ Be able to compare fairly:
■ The risk of skin irritation from sensors
■ The risk of a hacker obtaining POTUS’s therapy notes
■ The risk of being ignored
○ Be based on an all-encompassing framework
○ Provide trust in technology
○ Empower patients and professionals to make informed decisions
● Hypothesis/research questions
○ Transparency as a core value
○ OpenSource as a tool
○ Proactive rather than reactive compliance
● We have the opportunity to DESIGN this regulatory approach
○ At the same time we are designing AI
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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https://www.linkedin.com/groups/13990791/
(Group Music, Health and Technology)
www.atht.org
@TranspaTech
www.diapason.consulting
@DiapasonConsult
www.lilialaska.com
Melbourne 13 Feb 2022
Sydney 19 Feb 2022
w
ww.sofrenchysochic.com
2021 Symposium on Artificial Intelligence in Mental Health - Pierre Lonchampt et. al. WWW.DIAPASON.CONSULTING www.ATHT.ORG
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Required Evolution for the Regulatory framework:
(ref www.diapason.consulting/20210908
● Lean and Agile, Ad-Hoc (Bottom-up)
● Embedded and Participative, Incl. Ethicist
● Culture of ETHICS
● Global
● Continuous - Efficient
● Inclusive
● Transparent
Hypothesis:
‘Proactive transparent accountability’ is better than ‘benchmark
compliance’